[2] Whether the “reasons attributable to a patentee” under Article 91(2) of the former Patent Act includes the grounds related to the exclusive licensee and non-exclusive licensee who filed an application for permission, etc. necessary to obtain the registration of extension of a patent term when determining the “reasons attributable to a patentee”

[3] In a case where a person who has obtained permission or registration pursuant to the Pharmaceutical Affairs Act, etc. in order to implement an invention of a drug, etc. files a petition for trial to invalidate the registration of extension under Article 134(1)3 of the former Patent Act on the grounds that the extended period exceeds the period during which the patent was not practicable under Article 89 of the former Patent Act on the grounds that the delayed period of permission, etc. was included within the extended period due to a cause attributable to the person who has obtained permission

[4] Even if the examination of supplemental requirements for the application for permission for manufacture, sale, and import of drugs by the Ministry of Food and Drug Safety failed to proceed with the examination of supplemental data by the request of any of the Review departments of the Ministry of Food and Drug Safety, in cases where the procedures of examination, etc. for permission for manufacture, sale, and import of the relevant drugs have been continued in the past, whether the procedure of permission, etc. may be deemed to be delayed due to a cause attributable to the person who obtained permission or registration

1. As to the grounds of appeal Nos. 1 through 4

A. In order to implement an invention of a medicine, etc., permission, etc. is required to be obtained in accordance with the Pharmaceutical Affairs Act, etc. to promote the public health and sanitation and to ensure safety and effectiveness of the invention. A patentee is at a disadvantage in failing to implement the patented invention in the process of obtaining such permission, etc. Therefore, Article 89 of the former Patent Act (amended by Act No. 11117, Dec. 2, 201; hereinafter the same) provides that “in order to remedy such disadvantage and protect and encourage the invention of a medicine, etc., a patentee shall obtain permission, registration, etc. under other Acts and subordinate statutes, etc., to implement the patented invention, and in cases of an invention prescribed by the Presidential Decree requiring a long period of time due to a test of activation, safety, etc. necessary for such permission, registration, etc. (hereinafter referred to as “permission, etc.”), notwithstanding Article 88(1), the term of the relevant patent right may be extended by up to five years for the period during which it could not be implemented.”

However, Article 91(2) of the former Patent Act provides to the effect that “the period required for a cause attributable to a patentee shall not be included in the period during which the patented invention could not be worked.” Thus, where the procedure for permission, etc. is delayed due to a cause attributable to a person who obtained permission, etc., the period during which such cause is recognized shall not be included in the scope of extension of the term of a patent right. Meanwhile, the scope of a person who is entitled to apply for permission, etc. necessary to obtain registration of extension of the term of a patent shall include an exclusive licensee or non-exclusive licensee, other than the patentee, and thus, it is reasonable to interpret that “

In addition, a person who requests a trial to invalidate the registration of extension of term under Article 134(1)3 of the former Patent Act on the ground that the extended period exceeds the period during which permission, etc. is delayed due to a cause attributable to the person who has obtained permission, etc., and the extended period exceeds the period which could not work the patented invention under Article 89 of the former Patent Act, shall be liable to assert and prove such cause.

B. The lower court acknowledged the following facts based on the evidence duly admitted.

(1) On February 12, 2008, the defendant registered the patented invention of this case (patent registration number No. 804932) under the name of "the purpose of the patented invention in the field of Rodio siodiodiodiodiodiodiodiodiodio and blood response," concluded a non-exclusive license contract for the patented invention of this case with Bael Korea Co., Ltd. (hereinafter "Bael Korea"), and on July 22, 2009, Bael Korea registered the above non-exclusive license on July 22, 2009 (the actual defendant is the company that acquired the patent right after the application for patent term extension registration and the decision for the extension registration

(2) On March 13, 2008, LEL Korea filed an application for marketing approval of drug importation with respect to scquereltotos (raw materials: Babaums) subject to the instant permit related to the instant patent invention with the Minister of Food and Drug Safety, and filed an application for examination of criteria and method of examination, and filed an application for examination of drug information (DMF).

(3) The Minister of Food and Drug Safety requested LEL Korea to provide the first supplementary data on June 24, 2008 regarding the review of the criteria and method of testing, but notified DMF review on June 27, 2008 without a request for supplementary data. The Minister of Food and Drug Safety submitted the first supplementary data on July 24, 2008, but the Minister of Food and Drug Safety again requested the second supplementary data on August 31, 2008 by the Minister of Food and Drug Safety to submit the second supplementary data on August 11, 2008, and then approved the results of the review on the base and method of testing on the 12th of the same month.

(4) On August 27, 2008, LEL Korea submitted an application for marketing approval of drugs to the Minister of Food and Drug Safety on August 27, 2008 and an application for evaluation of the manufacturing and quality control standards of drugs (hereinafter “GMP”), and the Minister of Food and Drug Safety requested LEL Korea to provide supplementary data on November 26, 2008 on the examination of safety and effectiveness, but notification of the results on January 2, 2009 without any supplementary data. LEL Korea submitted supplementary data on February 18, 2009 related to safety and effectiveness examination to the Minister of Food and Drug Safety. The Minister of Food and Drug Safety granted marketing approval of the instant drug subject to permission on April 13, 2009.

(5) On July 13, 2009, the Defendant applied for registration of the extension to the Commissioner of the Korean Intellectual Property Office on September 22, 2009 with respect to the instant patent invention claims Nos. 1, (7), (8), (10), (12), and (13). On June 21, 2010, the extension registration (hereinafter “instant extension registration”) was completed on June 21, 201.

C. The lower court determined to the following purport based on the aforementioned factual basis.

(1) According to the above import item approval process, the period during which the patented invention of this case was not implemented shall be calculated based on the total of the period from March 13, 2008, which was the date of submission of a written request for examination of standards and testing method, to August 12, 2008, which was the date of approval of the result of examination, and the period from August 27, 2008, which was the date of submission of an application for import item approval, to April 13, 2009, which was the date of submission of an application

(2) When all of the data are submitted to the applicant under the relevant statutes, such as the Pharmaceutical Affairs Act at the time of the application for import approval, etc., the applicant cannot be deemed to have a duty of care to take measures to simultaneously proceed with all the examination procedures by making an application for import approval and a request for examination, and no other circumstance is found, such as requesting a separate examination with intent to delay the permission procedures. Therefore, it is reasonable to calculate the period of time including the period of time for the standard and examination, as well as the period of time for the standard

(3) In addition, even if the correction period is required due to one of the review departments of the Ministry of Food and Drug’s review departments, if the examination is being conducted by another department, it cannot be deemed that the permission was delayed due to the patentee’s fault, as long as the period overlaps with the period under which the examination is being conducted by another department, and thus, the overlap period cannot be excluded from the period under which the patented invention cannot be implemented.

(4) Accordingly, the Patent Tribunal did not err in the misapprehension of the legal principles as alleged in each of the plaintiffs' respective decisions, which determined that the extension of the registration of this case does not exceed the period calculated on the basis of the above paragraph (1) and the period delayed due to a cause attributable to the patentee's liability, and that there was no ground for invalidation under Article 134 (1) 3 of the former Patent Act in the registration of this case.

D. In light of the above legal principles and the relevant laws and records, the following is determined.

(1) Permission for manufacturing, selling, and importing items of medicine by the Ministry of Food and Drug Safety is granted to an application for permission according to the matters prescribed by Article 24(1) of the former Enforcement Rule of the Pharmaceutical Affairs Act (amended by Ordinance of the Ministry of Health and Welfare, May 6, 201), and specific procedures for examination, including the request for supplementation, are also conducted according to the internal circumstances of the relevant examination division. However, the above provision permits separate examination by examination items, and the examination by examination division is limited to the division of duties within the Ministry of Food and Drug, and all procedures for examination, etc. are to be completed. Ultimately, the procedure for examination by examination division, etc. by examination division, which is an intermediate process leading to final permission, can be evaluated as a whole as one procedure for permission.

In light of these circumstances, even if a request for supplement was made by a review division within the Ministry of Food and Drug Safety and the review of the request for supplement was not carried out until the report was submitted as a result, the period can also be deemed the period required for permission, unless there are other special circumstances. Thus, it cannot be readily concluded that the procedure for permission, etc. is delayed due to reasons attributable to a person who obtained permission, etc. on the ground that it is a period due to reasons attributable to the person who obtained permission, etc.

(2) According to the reasoning of the lower judgment, there is no evidence to acknowledge the period during which the examination of the Ministry of Food and Drug Safety was not conducted at all, and the period to be excluded from the “reasons attributable to a person who obtained permission, etc.” during the registration of the instant extension, and thus, there is no ground for invalidation under Article 134(1)3 of the former Patent Act.

(3) Therefore, the lower court’s conclusion that the instant registration was lawful is acceptable. Contrary to the allegations in the grounds of appeal, it did not err by misapprehending the legal principles on the cause and duty of care of patentees related to the calculation of extension of the duration period, and proximate causal relation between the cause and the period spent for permission, etc., and the principle of equality as prescribed by the Constitution

2. As to the fifth ground for appeal

A. The lower court determined as follows on the grounds stated in its reasoning.

(1) As a ground for invalidation of provisional registration under Article 134(1)2 of the former Patent Act, “the case where a registered non-exclusive licensee has registered the extension of a patent right with respect to an application for which no permission, etc. has been obtained” means that the scope of a non-exclusive licensee is included in the scope of a person eligible to apply for permission, etc. necessary to obtain registration of extension of patent term. However, in light of the essential matters in the application for registration of extension of patent right and evidentiary materials, if the registration of a non-exclusive licensee has been registered with omission, it is reasonable to interpret that the registration should be invalidated because the non-exclusive licensee fails to meet the lawful registration requirements. On the contrary, the purport that the non-exclusive licensee who applied for the permission, etc. should complete

(2) The Republic of Korea was in the position of a non-exclusive licensee who can legally practice the patented invention of this case at the time of the application for permission for import, and all documents submitted to the examiner of the Korean Intellectual Property Office regarding the registration of non-exclusive license and the submission of evidentiary materials regarding the registration before the certified copy of the decision on registration extension of this case was served

B. Examining the reasoning of the lower judgment in light of the relevant statutes and the records, including the duly admitted evidence, the lower court’s determination is acceptable, and contrary to what is alleged in the grounds of appeal, there were no errors by misapprehending the legal doctrine on the interpretation of Article 134(1)2 of the former Patent Act.

3. Conclusion

Therefore, all appeals are dismissed, and the costs of appeal are assessed against the losing party. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Park Sang-ok (Presiding Justice)